GB2608504A

GB2608504A - Wearable medication adherence monitoring device

Info

Publication number: GB2608504A
Application number: GB2207687.1A
Authority: GB
Inventors: Price Dawn
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-10-25
Filing date: 2020-12-28
Publication date: 2023-01-04
Also published as: US20220361810A1; WO2021079358A1; GB202207687D0; AU2020370233A1; EP4049284A1

Abstract

A wearable medication adherence monitoring (MAM) device for wearing by a patient, comprising an operating unit (OU) which comprises: a wireless communications unit (WCU); a processing unit (CPU); a memory unit; and one or a plurality of peripheral interface(s) with a plurality of input peripherals; and further comprising the plurality of input peripherals and output peripherals in a MAM unit (MAMU) which comprises: an interactive visual display unit (VDU) comprising a visual display (VD) and a VD patient interaction (PI) tool (VDTOOL); and an interactive audio platform (AP) comprising an audio output unit (SPK) and an audio PI tool (MIC; and one or a plurality of sensor unit(s) (SU(s)) comprising at least one biomarker sensor, and optionally at least one biometric sensor; comprised in one or a plurality of attachment units (AU) for wearing of the device on or about a body part of the patient.

Claims

1 . A wearable medication adherence monitoring (MAM) device for wearing by a patient, comprising an operating unit (OU) which comprises: a wireless communications unit (WCU) comprising a communications interface for accessing at least one communications network and for communication of data and signals between the device and a remote address comprising a MAM centre (MAMC); a processing unit (CPU); a memory unit; and one or a plurality of peripheral interface(s) with a plurality of input peripherals configured to send data and/or signals to the OU and a plurality of output peripherals configured to receive data and/or signals from the OU; wherein the OU is configured to access and store, process, output and/or communicate data and signals relating to medication adherence (MA), including data relating to digitised medication dose charts; and further comprising the plurality of input peripherals and output peripherals in a MAM unit (MAMU) which comprises: an interactive visual display unit (VDU) comprising a visual display (VD) and a VD patient interaction (PI) tool (VDTOOL); and an interactive audio platform (AP) comprising an audio output unit (SPK) and an audio PI tool (MIC), configured for VD and/or audio PI and MAMC interaction (Cl) and generating PI data and/or signal(s) relating to MA wherein each of VD and SPK comprises an interface for receiving data and/or signals from the OU and each of VDTOOL and MIC comprises an interface for sending data and/or signals to the OU; and one or a plurality of sensor unit(s) (SU(s)) comprising at least one biomarker sensor, and optionally at least one biometric sensor configured for sensing a patient biomarker(s) and optionally a patient biometric marker(s) or indicator(s) of MA and generating patient physical and/or mental wellbeing (PPMW) data or signal(s) indicative of MA wherein each SU comprises an interface for sending data and/or signals to the OU; and further comprising OU and MAMU comprised in one or a plurality of attachment units (AU) for wearing of the device on or about a body part of the patient, more particularly on or about a forearm or part thereof such as wrist or hand or finger of the patient; wherein one or both of MIC and an SU is an acoustic sensor (AS) configured to generate high fidelity patient audio signals in the frequency range of human speech and/or human vocalisation, for voice and/or vocal analysis indicative of MA; one or a plurality of SU(s) comprise a sensor material or a sensor system comprising a combination of material(s) which is an active smart material or an active smart system which is responsive to a patient stimulus by a response comprising a reversible measurable material property change, preferably wherein the response is self-powered or is powered by the stimulus; and wherein the input peripherals comprise VDTOOL, MIC and SU(s) and are comprised in a triangulation source environment of the MAMU configured to send data and/or signals relating to and indicative of MA to the OU from at least three sources including PI, patient voice and/or vocalisation and PPMW for local or remote triangulation thereof, and the output peripherals comprise VD and SPK and optionally additionally one or a plurality of SU(s) and are comprised in a triangulation control environment of the MAMU configured to receive data and/or signals relating to MA from the OU for direct or indirect control of said triangulation source environment.

2. The device as claimed in claim 1 , which is an embedded integrated system, wherein the one or a plurality of AU(s) is a communication and/or network housing which houses the OU, and peripherals, and comprises communication and/or network hardware, whereby the device is competent to perform a MAM task, enabled by the housing of peripherals in communication with the OU and in communication with a patient wearing the device, wherein the AU(s) is a shaped housing for the attaching of the device to the patient, the integration, connectivity and/or networking of units and of units with the patient.

3. The device as claimed in claim 2, which is partially or fully self-powered, wherein the device comprises one or a plurality of power supply unit(s) (PSU(s)), wherein a PSU comprises one or a plurality of power supplies selected from an energy harvesting unit (EHU) configured for drawing energy from one or more energy sources of the patient and/or of the patientâ s environment selected from biomechanical or mechanical energy such as vibrational or kinetic, acoustic or thermal energy such as kinetic or kinetic potential energy, solar or internal light energy, RF energy, ionic such as salinity gradient energy, electric potential or chemical energy and combinations thereof or energy form disclosed herein, and a wireless energy receiver (WER) configured for wirelessly receiving electromagnetic, electric or magnetic energy, and a combination thereof, and one or a plurality of energy storage cell(s) (ESC(s)) selected from a capacitor, supercapacitor and rechargeable battery and combinations thereof.

4. The device as claimed in claim 3, wherein a plurality or all of PSUs and/or ESCs make up a central or distributed power supply system (PSS) and/or energy storage system (ESS).

5. The device as claimed in claim 4, wherein the one or a plurality of AU(s) is a power supply and/or energy storage housing which houses the PSS and/or ESS and comprises embedded power supply and/or embedded energy storage hardware, whereby the device is competent to perform a MAM task.

6. The device as claimed in claim 5, wherein one or a plurality of PSUs and/or ESCs are local PSUs and/or ESCs.

7. The device as claimed in any one or a combination of claims 3 to 6, wherein a PSU or a PSS comprises a combination of two or more EHU(s) configured for harvesting different energy forms.

8. The device as claimed in any one or a combination of claims 3 to 7, wherein an EHU and/or WER comprises one or a combination of a smart material or smart system which is responsive to a stimulus of the patient or the patientâ s environment by a response comprising a reversible material property change.

9. The device as claimed in any one or a combination of claims 3 to 8, wherein an EHU and/or WER comprises a material or system selected from ferroelectric, piezoelectric, triboelectric, thermoelectric, pyroelectric, photovoltaic, magnetostrictive, electromagnetic and combinations thereof.

10. The device as claimed in any one or a combination of claims 3 to 9, wherein a PSU comprises a power management IC (PMIC) for conversion of harvested and/or received energy such as unregulated voltage and current into regulated energy for supply to one or a plurality of load(s) (a unit or part thereof) and for storage.

11. The device as claimed in claim 10, wherein a PMIC comprises circuits for protecting the load(s) and ESC(s).

12. The device as claimed in any one or a combination of claims 10 to 11 , wherein a PSU and/or PSS comprises a plurality of power supplies in parallel and a management controller connected to the plurality of power supplies by a management bus interface.

13. The device as claimed in any one or a combination of claims 4 to 12, wherein a PSS comprises a plurality of PSUs and a controller and a serial bus which connects the PSUs in a daisy chain, wherein the controller is connected to first and last ones of the PSUs by the serial bus.

14. The device as claimed in any one or a combination of Claims 1 to 13, wherein the MAMU is comprised in an intra-responsive triangulation environment additionally comprising a responsive control unit (RCU) comprising a controller, a memory unit, a PSU or comprised in a PSS and one or a plurality of peripheral interfaces for input peripherals comprised in the triangulation source environment and for output peripherals and input/output peripherals comprised in the triangulation control environment as hereinbefore defined, and wherein the RCU is configured to receive data and/or signals relating to and indicative of MA from said triangulation source environment of the MAMU and to generate and send responsive triangulation control data and/or signals to said triangulation control environment of the MAMU.

15. The device as claimed in Claim 14, wherein the intra-responsive triangulation environment is a communication environment comprising electrical and/or optical circuitry and/or SR-RF interfaces interfacing each peripheral with the RCU.

16. The device as claimed in any one or a combination of Claims 1 to 15, wherein the at least one biomarker sensor is at least one of cardiovascular, respiratory and circulatory sensors.

17. The device as claimed in any one or a combination of Claims 1 to 16, wherein the at least one biomarker sensor is selected from body temperature, heart rate, pulse, blood pressure, respiratory rate, oxygen saturation and hydration.

18. The device as claimed in any one or a combination of Claims 1 to 17, wherein the at least one biomarker sensor includes a sensor of body temperature and a sensor of heart rate.

19. The device as claimed in any one or a combination of Claims 1 to 18 additionally comprising a sensor of a marker or indicator of motivation to take medication such as a mood sensor, sleep sensor, appetite sensor, activity sensor.

20. The device as claimed in any one or a combination of Claims 1 to 19 additionally comprising a sensor of a marker or indicator of patient motivation to take medication which is a sensor of the device not being worn or being worn by a person other than the patient, comprising a biometric sensor of an identifier of the patient, selected from an iris, face or fingerprint sensor or AS configured for recognition thereof.

21 . The device as claimed in any one or a combination of Claims 1 to 20 which comprises a marker- of-self (MoS) (micro)processor or MCU which may be comprised in the OU or MAMU comprising peripheral interface(s) with input peripheral(s) VDTOOL and optionally additionally MIC and output peripheral(s) VD and/or SPK configured to receive MA data and/or signals from input peripheral(s) and to send MoS data and/or signals to output peripheral(s), wherein the device is configured to present, i.e. display or emit a visual or audio MoS to the patient.

22. The device as claimed in any one or a combination of Claims 1 to 21 wherein the AU(s) comprises a band configured to encircle a part of a patientâ s forearm such as a wristband.

23. The device as claimed in any one or a combination of Claims 1 to 22 wherein the AU(s) is deformable, resiliently deformable or flexible and configured for conformal contact with patient skin and wherein one or a plurality of units or parts thereof are flexible.

24. The device as claimed in any one or a combination of Claims 1 to 23 wherein the AU(s) comprises a surface comprising a display face configured to face outwardly to the patient body and a contact face configured to face inwardly to and to contact the patient body, wherein the surface encloses an AU body, wherein VDU and AP or parts thereof are comprised on or in the surface display face, and OU or parts thereof are embedded within the surface and/or body such as recessed or partially or fully enclosed and wherein PSU(s) and SU(s) are comprised at or in a surface or embedded within the body.

25. The device as claimed in any one or a combination of Claims 1 to 24 which is wearable on or about the wrist of a patient, wherein the AU(s) comprises a surface comprising a display face configured to face outwardly to the patient body and a contact face configured to face inwardly to and to contact the patient body, wherein the surface encloses an AU body, wherein the at least one sensor unit(s) are embedded in the AU at a contact face thereof configured for optical or physical contact with the patientâ s wrist.

26. The device as claimed in any one or a combination of Claims 1 to 25 wherein the AU comprises an extruded or 3D or 4D printed flexible material or combination of materials which is flexibly toughened or reinforced and waterproofed, for example comprising heat, solvent, water or cut-resistant material(s) or filler(s) or surface.

27. The device as claimed in any one or a combination of Claims 1 to 26 wherein AU comprises different material or combinations of materials, in a plurality of layers, zones or phases, selected from transparent, insulating or opaque, such as optically, acoustically or SR-RF, cushioning such as gel (e.g. silicone), embedding, adhesive and/or smart material and combinations thereof and the like. For example, transparent, adhesive, cushioning or smart material may be comprised at the contact face or a part thereof, and/or optically or acoustically transparent material may be comprised at the viewing face or a part thereof and/or SR-RF opaque material or hydrophobic material may be comprised at the surface and/or electrically insulating, SR-RF transparent, i.e. radiolucent embedding and/or smart material may be comprised in the body.

28. The device as claimed in any one or a combination of Claims 1 to 27 wherein AU comprises an energy storage environment and/or power supply, comprising wearable energy storage and/or power supply material which is flexible and editable, suitably comprising electrode nanowires or nanofibers or core-shell yarn thereof.

29. The device as claimed in any one or a combination of Claims 1 to 28 wherein AU comprises a near field communication (NFC) environment, comprising wearable SR-RF conducting material.

30. The device as claimed in any one or a combination of claims 1 to 29 which is a wearable embedded integrated MAM device comprising an OU and input, output and input/output peripherals comprising MAMU units as herein defined, housed within an AU which comprises a housing body and a housing surface having a viewing face and a contact face, wherein the VDU is embedded at and within the viewing face and the AP is embedded within the viewing face and/or the body and/or an AS is embedded at and/or within the contact face, and wherein one or a plurality of SU(s) are embedded at and/or within the contact face and/or within the body, wherein the AU provides a PSS environment comprising EHUs comprised at the contact face and the viewing face and optionally within the body, and an NFC environment wherein a plurality of units or parts comprise NFC interface and/or a plurality of units or parts thereof are comprised in an optically or electrically wired or wireless environment, more particularly a mixed output and input environment, most particularly a VD, SPK, VDTOOL, MIC and SU(s) environment comprising a system-on-a-chip housed within the AU body and surface.

31. The device as claimed in any one or a combination of Claims 1 to 30 comprising a wearable wireless network-on-a-chip (NoC) comprising units embedded in an AU body and/or within an AU surface comprising a shaped flexible, semi-flexible and/or rigid chip substrate, and networked by wireless communication channels connecting units and ICs.

32. The wearable device as claimed in any one or a combination of Claims 1 to 31 which is satellite- enabled or 4G-enabled or 5G-enabled, comprising one or more antenna for example omnidirectional antenna, or chipset(s), including SIM and eSIM, or one or more radiofrequency integrated circuit(s) (RFIC) therefor, including (monolithic) microwave integrated circuit(s) (MMMIC) or a combination thereof.

33. A wearable device as claimed in any one or a combination of Claims 1 to 32 wherein one or more sensors comprise a material or system selected from piezoelectric, triboelectric, magnetostrictive, electromagnetic, pyroelectric or thermoelectric, shape memory, pH-sensitive, thermochromic, chromoactive, chemochromic, photoactive, electroactive, photoelectric and combinations thereof.

34. A wearable device as claimed in any one or a combination of Claims 1 to 33 comprising at least two biomarker sensors and an AS which comprise a piezoelectric and/or triboelectric material or system.

35. A wearable device as claimed in any one or a combination of Claims 1 to 34 wherein one or more sensors comprise a material or system comprising one or more shaped component(s), such as membrane, foil, sheet, block, foam, film such as thin film, fibre, rod, bar, wire, electrode, cylinder, tube or nanotube, metamaterial or the like or a combination thereof including 2D and 3D arrays or matrices, bicomponent shaped materials such as bilayers or laminates, woven, knitted, braided, spaced or non-woven textiles of any combination thereof, which may be profiled such as curved or coiled or straight, nanostructured or nanotextured and may have a memorised shape which is different to an ambient shape.

36. A wearable device as claimed in any one or a combination of Claims 1 to 35 which comprises a voice capture unit, voice analysis unit or voice processing unit or capacity (VCU, VPU), e.g. comprised within the MIC or in the OU or RCU, interactive with MIC.

37. The wearable device as claimed in any one or a combination of Claims 1 to 36 which is an advisory wearable device, wherein the attachment is flexible or conformable and comprising a biometric sensor of a marker or indicator that the device is being worn and worn by the patient, comprised in a part of the MAMU or the AU which is configured for operation by patient touch, such as the VDTOOL, an AP control such as volume control, call initiate or accept and the like wherein the VDU and AP outputs are configured to output a MoS of motivation to take medication based on device wear-time.

38. The device as claimed in any one or a combination of claims 1 to 37 wherein an EHU is a hybrid EHU configured to harvest a combination of energies from different sources, preferably a hybrid NG comprising two or more systems or mechanisms which may be in series or parallel, such as a solar NG and a piezoelectric or triboelectric NG in series.

39. The device as claimed in any one or a combination of claims 3 to 38 wherein wearable power supply material and/or wearable energy storage material comprises mono, bicomponent or multicomponent nanowires or nanofibers or core-shell yarn, woven, knitted, braided, spacer and non-woven fabrics thereof comprising smart material(s) or electrode material(s) as hereindefined or combinations thereof, such as polymer, glass, composite or carbon based solar cells, smart systems or electrode material e.g. polymer, graphene, CNT or carbon fibre solar cells, fiber-based EHUs or NGs or electrodes.

40. The device as claimed in any one or a combination of claims 3 to 39 wherein a PSU or PSS comprises a plurality of a photo-voltaic solar EHU which may be dye-sensitised, a mechanical energy EHU or a thermal energy EHU

41 . The device as claimed in any one or a combination of claims 3 to 40 wherein PSU and/or ESC comprise nanostructured material such as porous, holey or aerogel.

42. The device as claimed in any one or a combination of claims 1 to 41 wherein VDTOOL is a selection tool configured for touch or voice selection of displayed content, for example wherein VD is touch sensitive or voice-responsive.

43. The device as claimed in any one or a combination of claims 1 to 42 wherein VD comprises a flexible polymer organic LED (OLED).

44. A wearable device of any one or a combination of claims 1 to 43 which is a modular wearable device, or a kit therefor wherein units are comprised in a plurality of independently wearable modules comprised in one or a plurality of AUs wherein a primary module comprises the OU, the VDU and the SPK and optionally one or a plurality of MIC and one or a plurality of SU, and one or a plurality of secondary modules comprises one or a plurality of SPK and/or one or a plurality of SU.

45. The wearable modular device of claim 44 which is a SR-RF communications environment wherein a primary module and at least one secondary module are SR-RF enabled, more particularly the device is a NFC communications environment and/or a BAN communications network such as a Bluetooth Smart environment wherein the primary module, more particularly the OU or RCU provides a SR-RF environment interface, interfacing with MAMU units in the or each primary and secondary module.

46. The device of any one or a combination of claims 1 to 45 for use in MAM, more particularly MAM in relation to medication for one or more chronic conditions or disorders such as diabetes, pulmonary and cardiac including COPD, cancer, mental health including psychiatric such as schizophrenia, palliative care, transfer therapy, contraception, neurology and the like or combinations with other medications.

47. A method for the manufacture of the device as claimed in any one or a combination of claims 1 to 46 or a device obtained by the method, which comprises laying up units or modules or parts thereof on a support such as a scaffold, which may be a pre-formed component of the attachment, and forming the attachment thereabout, wherein the attachment and a pre-formed scaffold are formed by means of 3D printing technique employing one or more polymers, copolymers or combinations thereof together with optional filler and the like selected from organic or inorganic substrates.

48. The device of any of claims 1 to 46 obtained or obtainable by the method of claim 47.

49. A computer implemented method for interactive bidirectional medication administration monitoring (MAM) for a patient in receipt of medication, by means of the wearable device as claimed in any of claims 1 to 47, comprising: a MAM step of causing the PU to access locally, such as in a memory unit, or remotely, such as at a MAMC address, data and/or signals relating to MA including data relating to a personalised MA program and to retrieve medication dose data together with MA status query; a PI control step of causing said interactive VDU and/or said interactive AP to display and/or emit said medication dose and status query; a PI step of causing said patient to be receptive to said dose status query and causing the interactive VDTOOL and/or interactive MIC to receive PI dose status data and/or signals relating to MA responsive to said query; a MA program updating step of causing said processor and memory unit to update said MA program with said PI dose status data and/or signals or to transmit said data and/or signals for remote updating; and a PI triangulation source step of causing said WCU to transmit in real time said PI data and/or signals to MAMC; and comprising a MoS sequence comprising: causing said processing unit to access PI data and/or signals locally, such as in a memory unit, or remotely, and to access or generate data and/or signals relating to MoS of MA and to issue MoS data and/or signals; a performance step of causing said interactive VDU and/or said interactive AP to display and/or emit said MoS of MA; optionally a PI step of causing said patient to be receptive to said displayed and/or emitted MoS of MA and causing said VDTOOL and/or MIC to receive PI responsive to said MoS of MA; and comprising a PPMW sequence comprising: a PPMW monitoring control step of causing the processing unit to access PPMW data and/or signals generated by a plurality of SUs and optionally additionally one or more AS(s) as a marker or indicator of MA; a PPMW triangulation source step of causing said WCU to transmit said PPMW data and/or signals to MAMC; and comprising a voice capture sequence comprising: a voice control step of causing a voice capture unit (VCU) to capture voice PI data and/or signals received by said MIC and/or received by said AS indicative of MA; and a voice triangulation source step of causing said WCU to transmit in real time said voice data and/or signals to MAMC; wherein the method comprises a triangulation sequence comprising: a triangulation step of causing a local or remote processor to receive said PI, voice and PPMW data and/or signals and to identify deviations from normal as an indicator of MA, wherein steps are self-powered by energy generated or received by the PSU(s) comprised within the device and wherein the PPMW data is generated by SU(s) response(s) to a patient stimulus indicative of MA which is self-powered or is powered by the stimulus and wherein the control steps control the generation of effective triangulation source data and/or signals.

50. The method as claimed in claim 49 comprising a responsive control sequence comprising: a triangulation source environment step of causing a responsive control unit (RCU) to access PI, voice and PPMW data and/or signals from at least three peripheral input sources and to identify deviations from normal as an indicator of MA in data and/or signals of any of the at least three sources; a responsive control step of causing the RCU to initiate a triangulation source routine task responsive to identifying any such deviation and to access or generate and issue responsive control data and/or signals relating to a PI request, voice request and/or PPMW data and/or signal request to one or more of the at least three output and input/output peripherals and causing said output peripherals to display or emit the PI request and causing said input/output peripherals(s) to generate and/or transmit said PPMW data and/or signals; optionally one or more iterations of the responsive control sequence; and a responsive control triangulation source step of causing said RCU to transmit in real time said responsive control data and/or signals to OU and to MAMC

51. A MAM system comprising a combination of a wearable device as claimed in any one or a combination of the preceding claims, together with a MAMC comprising a local or remote database and optionally additionally comprising one or more MAM personnel interfaces, such as one or more HP interfaces, and combinations thereof, said system comprising one or more storage media storing processor-executable instructions, one or more processors configured to execute said instruction and means for transmitting a data signal.

52. The wearable device of any of claims 1 to 48 when programmed to carry out the steps of the computer implemented method as claimed in any one or a combination of claims 49 and 50.